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Quantitative Data Mining for Drug-Adverse Event Safety Signal Detection Using MEDLINE
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Research Initiative
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FDA
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NLM
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The objective of this initiative between the National Library of Medicine (NLM) Cognitive Science Branch and the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA) is to develop a mutually beneficial automated data mining analytical tool in which NLM’s electronic databases and resources (including MEDLINE) are utilized to support the FDA’s mission related to enhancing postmarket drug safety surveillance and safe use.
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Radiation Biodosimetry Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIAID
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This working group is focused on regulatory and scientific issues regarding technologies and devices for radiation biodosimetry. The working group assisted in drafting the new Food and Drug Administration (FDA) Center for Device and Radiological Health (CDRH) guidance for industry.
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Radiation Emergency Medical Management (REMM)
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Resource Development
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CDC, OS
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NLM, NCI
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This activity is to develop a comprehensive web resource and mobile app. Radiation Emergency Medical Management (REMM) is a mechanism to collect, evaluate, collate, store, and make available electronically to health care professionals immediate, up-to-date, evidence-based clinical information they would use to treat civilian patients and others affected by radiation incidents.
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Radiation/Nuclear Technical Evaluation Review Panel
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Committee, Work group, Advisory group, or Task Force
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BARDA
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NIAID
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The National Institute of Allergy and Infectious Diseases (NIAID) participates on the Radiation/Nuclear Technical Evaluation Review Panel to review white papers and proposals received by the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) for the development of radiation and nuclear medical countermeasures. NIAID provides scientific and programmatic critiques and reviews of selected submissions.
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Radiobiology Bioterrorism Research and Training Group (RABRAT)
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Meeting/ Workshop
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FDA, OS
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NCI
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This activity involves monthly meetings to discuss research initiatives, funding opportunities, training, conferences, publications, and other events and information related to preparing the US Government to respond to nuclear terrorism.
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Reciprocal Educational and Training Partnerships between FDA/CDER and the NIH Clinical Center
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Training Initiative
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FDA
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CC, NCI, NIAID, NIDCR, NIDDK, NIMH, NINDS
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This activity is sponsored by the Clinical Pharmacology Program, Office of Clinical Research Training and Medical Education (OCRTME) at The National Institutes of Health (NIH) Clinical Center (CC). It consists of elective rotations at the Office of Clinical Pharmacology (OCP) and the Office of New Drugs (OND) of the US Food and Drug Administration''s (FDA) Center for Drug Evaluation and Research. It is for NIH staff, with a primary focus on clinical fellows and research fellows, who expressed an interest in learning more about FDA regulatory sciences applicable to drug development research. Rotating fellows are mentored by FDA staff on the required elements of an Investigational New Drug (IND) application and the key elements of the FDA review process from a regulatory perspective. This program also established a mechanism for FDA scientific reviewers at the OCP to rotate at the NIH CC and to interact with members of a clinical research team, thus acquiring a better perspective on clinical research protocol implementation and the requirements of an Institutional Review Board (IRB) at the NIH.
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Reentry Research Network
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Committee, Work group, Advisory group, or Task Force
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ACF, SAMHSA
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NIDA, OD/DPCPSI/OBSSR
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This is a subgroup that reports to the Federal Interagency Reentry Council. The purpose of this group is to bring together numerous federal agencies to make communities safer, assist those returning from prison and jail to becoming productive, tax-paying citizens, and save taxpayer dollars by lowering the direct and collateral costs of incarceration. The National Institute on Drug Abuse (NIDA) serves on the HHS Re-entry/CJ working group. Staff meets by phone monthly.
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RePORT South Africa
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Research Initiative
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CDC, OS
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NIAID
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RePORT South Africa is a jointly funded project between the National Institutes of Health (NIH), the US President''s Emergency Plan for AIDS Relief (PEPFAR), and the South African Medical Research Council and Department of Science and Technology to establish a consortium of Tuberculosis (TB) researchers in South Africa.
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Repurposing Food and Drug Administration Approved Drugs for a Radiation Indication Meeting Report
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Other
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BARDA, FDA
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NIAID
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The purpose of the meeting report is to inform all stakeholders concerning meeting discussions and recommendations from the conference held in 2017. The manuscript was written by the inter-agency team and published in Radiation Research in October, 2018.
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Research Evaluation and Commercialization Hub (REACH) Review Committee
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA
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NICHD, NCI, NHLBI, NIDA
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This trans-NIH group helps manage the NIH Research Evaluation and Commercialization Hub (REACH) Awards program to promote dissemination of evidence-based therapeutics, preventatives, diagnostics, devices, and tools into the marketplace.
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